Aim of the study: Herein, this meta-analysis study evaluated the efficacy of palifermin after HSCT on the incidence and severity of OM or aGVHD in hematologic malignancy patients in randomized clinical trials (RCTs). Materials and methods: To compare the efficacy of palifermin on adverse events, OM and aGVHD compared with placebo, we searched databases of PubMed/Medline, Web of Science and
Cochrane Library for RCTs based on a number of criteria. Results: There was no difference observed in the incidence of OM and aGVHD between two groups. The subgroup analysis didn't show significant differences in two groups for aGVHD grade 2-4 (odds ratio [OR] = 1.54, 95% confidence interval (CI): 0.70-3.39, p = 0.28), aGVHD grade 3-4 (OR = 0.97, 95% CI: 0.48-1.94, p = 0.92), OM grade 2-4 (OR = 0.76, 95% CI: 0.42-1.38, p = 0.37) and OM grade 3-4 (OR = 0.54, 95% CI: 0.25-1.15, p = 0.11], but erythema as an adverse effect in palifermin group was higher than placebo group (OR = 1.86, 95% CI: 1.10-3.15, p = 0.02]. Conclusions: This meta-analysis of six clinical trials found no statistically significant difference in OM and aGVHD grades in patients receiving 60 mug/kg/day dose of palifermin compared with those receiving a placebo. However, oral mucosal erythema was more prevalent among patients receiving palifermin than patients receiving a placebo.